Device typeOphthalmic/otologic diagnostic set: A collection of battery-powered devices intended to be used by a physician to perform an ophthalmic and/or otoscopic clinical examination on a patient. The devices are typically enclosed in a dedicated case and will typically include an ophthalmoscope and an otoscope, a dedicated interchangeable handle that contains the batteries which may be rechargeable and common to these examination devices, spare parts (e.g., extra ear specula, light bulbs) may include a line-powered charging station (e.g., desktop, wall-mounted) to house/charge these devices. This is a reusable device that may contain some disposable devices.
FDA categoryLight, Examination, Medical, Battery Powered
Device ID00634782053529
Catalog number5215-TH
AvailabilityOver the counter
MRI safetyLabeling does not contain MRI Safety Information